The GIRO Growth Modulation System

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Pega Medical, Inc.

The following data is part of a premarket notification filed by Pega Medical, Inc. with the FDA for The Giro Growth Modulation System.

Pre-market Notification Details

• Device ID: K220190
• 510k Number: K220190
• Device Name: The GIRO Growth Modulation System
• Classification: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
• Applicant: Pega Medical, Inc. 1111 Autoroute Chomedey Laval, CA H7W 5J8
• Contact: Ariel R. Dujovne
• Correspondent: Ariel R. Dujovne; Pega Medical, Inc. 1111 Autoroute Chomedey Laval, CA H7W 5J8
• Product Code: OBT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-24
• Decision Date: 2022-10-24

NIH GUDID Devices

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